Diabetes specialists at the University of Texas Southwestern Medical Center and nineteen other sites nationwide will conduct trials on 2,500 participants age 30 or older who have presented with prediabetes. Prediabetic individuals have higher blood glucose levels than normal, however not enough to be considered diabetic. The purpose of the trial is to determine if Vitamin D can prevent or delay diabetes.
UT Southwestern is in search of 150 to 200 prediabetic adults to participate in the trial. For information on becoming a participant please call 214-DIABETES (214-342-2383) to see if you qualify. A free blood test will be given to determine qualification. To learn more about UT Southwestern clinical trials, please visit clinical trials at UT Southwestern.
According to Dr. Philip Raskin, Professor of Internal Medicine, who will lead the UT Southwestern investigation, “There is some evidence that treatment with vitamin D can prevent development of type 2 diabetes. If you could prevent development of diabetes, that would save people a lot of anguish and diabetes medication cost.”
It has been estimated that 79 million Americans have prediabetes, according to the American Diabetes Association. Additionally, this is more than 3 times the number of people with full-blown diabetes. Around 8.3 percent of Americans, or nearly 26 million Americans have diabetes.
This clinical trial will administer 4,000 International Unites (IUs) of vitamin D3 (cholecalciferol) daily to participants to see if vitamin D3 can prevent diabetes. The recommended daily dose of vitamin D for adults runs between 600 and 800 IUs, however 4000 IUs is considered to be within safe limits. Raskin points out, “The side effects of vitamin D3 in the doses we’re going to use are few. It’s a fairly safe and inexpensive treatment”. According to the researchers, there is little risk of developing kidney stones or high levels of calcium in the blood or urine taking vitamin D. Previous studies indicate that vitamin D may decrease the risk of diabetes by 25 percent.
The current study will look at whether race, sex or age will play a role in the effects of vitamin D supplementation. This will be a double-blinded trial and all participants will receive twice-yearly check-ups.
UT Southwestern is also participating in the Glycemia Reduction Approaches in Diabetes. This is a comparative effectiveness study that will compare the pros and cons of four different type 2 diabetes treatments.